# Spectrum Medical, Ltd.

- Location (FDA's records): Gloucester, GB
- FDA decisions: 23 (2006–2026): 23 510(k) clearances
- Names in FDA's records: Spectrum Medical , Ltd. (15); Spectrum Medical S.R.L. (6); Spectrum Medical, Llp (2)
- Product codes: DRY (9), DTX (3), DTR (2), DTQ (2), KFM (2), DTN (1), DTZ (1), DWF (1), DWC (1), DWA (1)
- 510(k) review time since 2016: median 79 days, against 88 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 28 (11 its own); citations of its devices by later devices: 12 (11 its own)
- Recalls linked to its devices: 3 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sorin Group Deutschland GmbH: 4 (https://510kreport.com/company/sorin-group-deutschland)
- Qura S.R.L: 4 (https://510kreport.com/company/qura)
- 3M Health Care, Ltd.: 2 (https://510kreport.com/company/3m-health-care)
- Eurosets S.R.L: 1 (https://510kreport.com/company/eurosets)
- 3M Health Care, Sarns: 1 (https://510kreport.com/company/3m-health-care-sarns)
- Sorin Group Italia S.R.L.: 1 (https://510kreport.com/company/sorin-group-italia)
- 3M Company: 1 (https://510kreport.com/company/3m)
- Quest Medical, Inc.: 1 (https://510kreport.com/company/quest-medical)

## Firms that cite its devices most
- Maquet Cardiopulmonary, AG: 1 (https://510kreport.com/company/maquet-cardiopulmonary)

## Its most-cited devices
- K071725: M2 Monitor (2007), cited by 2
- K072131: M3 Monitor (2007), cited by 2
- K173591: Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas (2018), cited by 1
- K163657: Quantum Workstation (2017), cited by 1
- K062468: Spectrum M2 Monitor (2006), cited by 1
- K181942: Quantum Ventilation Module (2018), cited by 1

## Recent decisions
- K252541: Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W (Mar 12, 2026)
- K240934: Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3); (Mar 12, 2026)
- K251762: Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) (Aug 4, 2025)
- K240908: Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) (Jul 8, 2025)
- K250326: Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) (Jun 24, 2025)
- K241206: Quantum Perfusion Hybrid System (Jul 18, 2024)
- K241248: Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) (May 31, 2024)
- K212657: Quantum Heater-Cooler (May 6, 2022)

Source page: https://510kreport.com/company/spectrum-medical